Recalls & Field Safety Actions

Medical device recalls in India may be voluntary (initiated by the manufacturer) or CDSCO-directed. All recalls require a Field Safety Notice (FSN) to customers and healthcare facilities, and coordination with CDSCO. Recall notifications may be submitted via the SUGAM vigilance module or through other CDSCO-specified channels.

Official source: Medical Devices Rules 2017, Schedule 7; CDSCO

Recall Classification in India

Medical device recalls are classified based on severity and risk to public health:

• Class I: Device poses serious adverse health consequences or death
• Class II: Device may cause adverse health consequences but severity is not as serious as Class I
• Class III: Device is unlikely to cause adverse health consequences

Classification determines the urgency of communication, scope of recall, and CDSCO reporting requirements. Recalls may be expanded or downgraded based on evolving safety information.

CDSCO retains the authority to reclassify recalls based on evolving post-market surveillance data, adverse event reports, and additional safety information. Manufacturers must comply with any reclassification within timeframes specified by CDSCO. Recall expansion may be mandated if additional batches or device variants are found to pose similar risks.